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Zevalin-BEAM/BEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00514475
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : May 4, 2012
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:
The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients who are not in CR after induction therapy.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: 90Y-ibritumomab tiuxetan (Zevalin) Phase 2

Detailed Description:

Mantle cell lymphoma is considered to have the worst outcome of all non-Hodgkins lymphomas. Since 1997, the Nordic Lymphoma Group has conducted phase II studies in order to improve the results for this lymphoma subtype. The first study included high-dose therapy with autologous stem cell support in the first line of treatment. The results showed the importance of a high quality response to pre-transplant induction treatment, and that CHOP-based regimen alone did not achieve this. Thus, the second trial was designed to improve remissions by including Rituximab and high-dose Ara-C. Results now show that a high rate of molecular remission in the bone marrow was achieved, and the 3-year FFS was improved in comparison to the first study (80% vs 24%). Furthermore, patient who had a molecular relapse (t(11;14) or IgV-gene) were treated with 4 doses of Rituximab and many converted back to be PCR negative.

The present and thus third phase II study aims to improve the high-dose regimen by adding Zevalin radioimmunotherapy in patients who are not in CR prior to transplant. Data from the last trial show that patients not in CR at this point have a worse outcome (3 year FFS of 63%, vs 85% for CR patients). Monitoring for molecular relapse in the bone marrow will be done, and patients who become PCR positive will be treated with Rituximab in order to evaluate the value of this strategy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Therapy With Autologous Stem Cell Support in First Line Treatment of Mantle Cell Lymphoma- 90Y-Ibritumomab Tiuxetan in Combination With BEAM or BEAC to Improve Outcome for Patients Not in CR After Induction Treatment
Study Start Date : November 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Intervention Details:
  • Drug: 90Y-ibritumomab tiuxetan (Zevalin)
    90Y-ibritumomab tiuxetan (Zevalin) at 0.4 mCi/kg is administered one week prior to start high-dose chemotherapy (BEAM/BEAC) in patients who have not achieved CR after induction therapy. Predosing with rituximab 250 mg/m2 one weeks prior to radioimmunotherapy and the same day.

Primary Outcome Measures :
  1. Time to treatment failure (TTF) for PR/CRu patients receiving Zevalin-BEAM/BEAC [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Whole study ]
  2. TTF for CR patients receiving BEAM/BEAC [ Time Frame: 3 year ]
  3. Overall survival [ Time Frame: 5 year ]
  4. Time to progression [ Time Frame: 3 year ]
  5. Response rates [ Time Frame: 6 months ]
  6. Value of PET [ Time Frame: 6 months ]
  7. Molecular response rates [ Time Frame: 6 months ]
  8. Molecular response and progression-free survival after Rituximab for molecular relapse [ Time Frame: 5 years ]
  9. Microarray gene expression analysis [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Age 18 - 65 years.
  2. Histologically confirmed (according to the WHO classification) mantle cell lymphoma stage II-IV at time point of diagnosis. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin-D1 and most cases will have t(11;14) translocation.
  3. No previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase II study who can be transferred to NLG-MCL-III before evaluation at week 15.
  4. WHO performance status of 0 - 3.
  5. Life expectancy of more than 3 months.
  6. Written informed consent.

Exclusion Criteria:

  1. Severe cardiac disease: cardiac function grade 3-4 (Appendix 1).
  2. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.
  3. Pregnancy/lactation
  4. Men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.
  5. Known HIV positivity
  6. Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
  7. Known seropositivity for HCV, HbsAg or other active infection uncontrolled by treatment.
  8. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00514475

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Arne Kolstad
Oslo, Norway, 0310
Sponsors and Collaborators
Oslo University Hospital
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Study Chair: Arne Kolstad, MD Nordic Lymphoma Group
Principal Investigator: Christian Geisler, MD Nordic Lymphoma Group
Principal Investigator: Erkki Elonen, MD Nordic Lymphoma Group
Principal Investigator: Anna Laurell, MD Nordic Lymphoma Group

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Oslo University Hospital, MD PhD Identifier: NCT00514475     History of Changes
Obsolete Identifiers: NCT00505674
Other Study ID Numbers: 2005-002003-17
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2008
Keywords provided by Oslo University Hospital:
Mantle cell lymphoma
90Y-ibritumomab tiuxetan
High-dose therapy
First line
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs